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Comparison of the Efficacy of two brands of Methylphenidate (Stimdate® with Ritalin®) in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized, Clinical Trial

Protocol summary

Summary
The aim of this double blind trial was to compare the efficacy of Stimdate (methylphenidate-MPH produced in Iran) with Ritalin (methylphenidate’s original brand) in children with ADHD. A total of thirty, 6-16 year-old children, who met inclusion and exclusion criteria; were studied in a comparative, double blind, randomized, clinical trial, in child psychiatric clinic of Tehran Psychiatric Institute, during 2008. The participants were randomly enrolled in the two groups to receive 10-40mg (in two divided daily doses) of two brands of MPH (Ritalin or Stimdate) for 6 weeks (4 weeks of fixed, 5-20mg MPH per dose) and 2 weeks of optimal dose (the best fixed-dose week). Side effects profile, Parent’s Conner’s Rating Scale (PCRS), Child Symptom Inventory-4-(CSI-4), Clinical Global Impressions (CGI), and Children’s Global Assessment Scale (CGAS) were compared between groups at the baseline, and at the end of the 4th and the 6th week.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106306923N1
Registration date: 2011-11-04, 1390/08/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-11-04, 1390/08/13
Registrant information
Name
Elham Shirazi
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 5680
Email address
eshirazi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2008-04-20, 1387/02/01
Expected recruitment end date
2008-12-21, 1387/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of two brands of Methylphenidate (Stimdate® with Ritalin®) in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized, Clinical Trial
Public title
The Efficacy of Stimdate and Ritalin in Children with ADHD: A Comparative, Double-Blind, Randomized, Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 6-16 years old; Presence of mixed AD/HD according to Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV), No psychological medication in 2 weeks prior to the study; signing informed written consent of parents to participate in the study; the ability to comply study visits schedule. Exclusion criteria: Presence of clinically significant gastrointestinal problems, cardiovascular disease, glaucoma, seizure disorder, psychotic disorder, clinical depression, or Tourette's syndrome; Co-morbid conditions including oppositional defiant disorder or conduct disorder, pervasive developmental disorder, depression, or learning disorders
Age
From 6 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
faculty of medicine, Iran University of Medical Sciences, Hemmat Exp.
City
Tehran
Postal code
Approval date
2009-06-23, 1388/04/02
Ethics committee reference number
11180

Health conditions studied

1

Description of health condition studied
ADHD
ICD-10 code
F90
ICD-10 code description
A group of disorders characterized by an early onset (usually in the first five years of life), lack of persistence in activities that require cognitive involvement, and a tendency to move from one activity to another without completing any one, together

Primary outcomes

1

Description
Clinical Profile of illness reported by parents
Timepoint
4th and 6th week
Method of measurement
The Standard Persian version of Conner’s parent rating scale-revised (CRS-R) was used for the assessment of ADHD in children and adolescents.

2

Description
efficacy of treatment
Timepoint
4th and 6th week
Method of measurement
The Clinical Global Impressions (CGI) Scale used to rate the symptoms change over time, and efficacy of medication, taking into account the patient’s clinical condition by clinicians.

3

Description
symptoms severity reported by parents
Timepoint
0,4,6 weeks
Method of measurement
The Child Symptom Inventory-4 (CSI-4) (ADHD part): is also used to measure Symptom Severity scores by teachers and parents24-25. The internal consistency reliability for CSI-4 in literature reported to be 0.74-0.94 and have acceptable criterion validity.

4

Description
illness severity
Timepoint
4th and 6th week
Method of measurement
The Children’s Global Assessment Scale (CGAS) is used to measure the overall severity of disturbance in children. The CGI and CGAS showed acceptable reliability and validity scores in different studies.

Secondary outcomes

1

Description
Drug side effects
Timepoint
4th and 6th week
Method of measurement
checklist by clinical interview and exam

Intervention groups

1

Description
Intervention Group: In this group 15 subjects with ADHD were treated with Stimdate® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 20mg at morning and noon in the 4th week. The dose of the 5th and 6th week was determined according to best response to doses.
Category
Treatment - Drugs

2

Description
The control group contained 15 subjects who were treated with Ritalin® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 20mg at morning and noon in week four. The dose of Ritalin in the 5th and 6th week was determined according to best response to doses.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Psychiatry Institute
Full name of responsible person
Street address
#1, Shahid Mansouri St., Niayesh St., Sattarkhan Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Eftekhar Ardebili
Street address
Mental Health Research Center, Tehran Psychiatric Institute, Shahid Mansouri St., Niayesh St., Sattarkhan Ave., Tehran, 1443813444, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Elham Shirazi
Position
Associate professor
Other areas of specialty/work
Street address
No.1, Shahid Mansouri St., Niayesh St., Sattarkhan Ave.
City
Tehran
Postal code
1443813444
Phone
+98 21 6650 6862
Fax
+98 21 6650 6862
Email
shirazi_elham@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Elham Shirazi
Position
Associate Professor
Other areas of specialty/work
Street address
No1. Shahid Mansouri St., Niayesh St., Sattarkhan Ave.
City
Tehran
Postal code
1443813444
Phone
+98 21 6650 6862
Fax
+98 21 6650 6862
Email
shirazi_elham@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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